SOMNOscreen plus PSG+ BT AASM Set SBT201AU

GUDID 04250413401987

SOMNOmedics GmbH

Patient monitoring system module, multifunction
Primary Device ID04250413401987
NIH Device Record Key641ff630-3bc8-4d0d-8e8a-8fd65a36bb30
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOscreen plus PSG+ BT AASM Set
Version Model NumberSBT201AU
Catalog NumberSBT201AU
Company DUNS314112173
Company NameSOMNOmedics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250413401987 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-05
Device Publish Date2016-09-23

Devices Manufactured by SOMNOmedics GmbH

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04250413402755 - SOMNOwatch plus ACTI2023-12-15
04250413410781 - SOMNO HD / ECO accessory2023-12-08
04250413410828 - SOMNOscreen ECO EEG 322023-12-08
04250413410835 - SOMNOtouch RESP accessory2023-12-08
04250413410842 - SOMNOtouch RESP accessory2023-12-08
04250413410859 - SOMNOtouch RESP accessory2023-12-08
04250413400522 - SOMNOscreen Plus accessory2023-09-04

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